[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint (PJI)

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ClinicalTrials.gov Identifier: NCT01705496

Recruitment Status
:
Terminated
(The sensitivity and specificity were not able to be assessed in this study due to the poor image quality.)

Estimate the Sensitivity and Specificity of [124I]FIAU [ Time Frame: 30 hours ]

The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.

Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.

Secondary Outcome Measures
:

Evaluate the Safety and Tolerability of [124I]FIAU [ Time Frame: 30 +/- 2 days ]

Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.

The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.

The trial failed primary outcome, and this secondary outcome was not analyzed

Other Outcome Measures:

Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards [ Time Frame: 30 +/- 2 days ]

An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.

The trial failed primary outcome, and this secondary outcome was not analyzed.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males or females age >18 years

Ability to provide informed consent

A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment

Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint

Prosthetic joint implant that has been in site for more than 3 months prior to enrolment

Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent

Women must be either postmenopausal or surgically sterile

Ability to return for all study assessments

Clinically euthyroid, or on stable thyroid replacement therapy

Exclusion Criteria:

Subjects who are unable to comply with study requirements

Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning